Kornimate/medical-research-clean huggingface dataset:
safety, tolerability and pharmacodynamic activity of jnj-26528398 in healthy male participants

Conditions: Healthy Participants

Summary: the purpose of this study is to evaluate the anti-inflammatory properties of jnj-26528398 using an intravenous (iv) endotoxin-induced model of acute, transient inflammation.

this is a 2-part, single center, double-blind study (neither physician nor participant knows the treatment that the participant receives). part 1 is designed to evaluate the safety, tolerability, and pharmacokinetics (level of drug in the blood) of a dosing regimen of an investigational drug (jnj-26528398) prior to its use in part 2. in part 1, participants will be assigned by chance to receive either 3 mg/day jnj-26528398 (6 participants) or placebo (3 participants) for 7 consecutive days while staying in the clinic for 10 days. placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. part 2 is designed to evaluate the anti-inflammatory properties of jnj-26528398 by measuring markers of inflammation in the blood after intravenous (iv) administration of a substance (endotoxin) which activates the immune system and temporarily causes flu-like symptoms. in part 2, participants will be assigned by chance to receive up to 3 mg/day jnj-26528398 (6 participants) or placebo (4 participants) for up to 7 consecutive days while staying in the clinic for 10 days. endotoxin will be given on the last day of study drug administration. participants will remain in bed for at least 6 hours after endotoxin administration and will be closely monitored by study personnel.

Eligibility criteria:
inclusion criteria: * nonsmoker * be in good health on the basis of physical examination, medical history, and electrocardiogram (ecg) * must have good exercise tolerance * have a body mass index of 18-29 kg/m2, inclusive, and body weight between 60 and 85 kg, inclusive * have a history of consistent dental hygiene and dental care * must adhere to required contraception (subject and partner, if applicable) during the study and for 3 months after study * must agree to not donate sperm during the study and for 3 months after study exclusion criteria: * is currently enrolled in an investigational study, has recently received an investigational drug (including investigational vaccines), or has donated blood within 3 months * has had a vaccination within past 3 months * has history of significant drug or alcohol abuse within past 2 years or has a positive drug screen * blood donation within past 3 months * part 2 only: has received endotoxin within past 3 months, or has a known allergy or history of significant adverse reaction to endotoxin or its excipients lactose and polyethylene glycol 6000

Keywords: healthy participants pharmacodynamic pharmacokinetics intravenous endotoxin-induced model acute inflammation jnj-26528398 anti-inflammatory
feasibility study of a 4 stage bowel obstruction cancer diet

Conditions: Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Colorectal Adenocarcinoma; Colorectal Cancer Metastatic; Ovarian Cancer; Ovarian Neoplasm; Metastatic Colorectal Cancer; Metastatic Ovary Cancer; Peritoneal Carcinomatosis; Bowel Obstruction

Summary: bowel obstruction is a common complication in patients with ovarian, peritoneal and bowel cancer due to a mass or spread of disease, causing narrowing to the gut, as these cancers can grow on the bowel surface. certain foods may lead to symptoms such as pain, bloating, feeling full, feeling sick, vomiting and difficulty passing a bowel motion. there is limited evidence to establish the best diet to follow when someone is diagnosed with the risk of bowel obstruction and is experiencing symptoms after eating and drinking. the dietitians at the royal surrey have developed a 4 stage bowel obstruction diet which they have been using with patients for 3 years. the 4 stages are clear fluids, all thin liquids, low fibre soft smooth diet, low fibre soft sloppy diet. depending on the severity of symptoms and the risk of a blockage, patients are asked to follow a certain stage of the diet. they are advised to move up and down the stages as symptoms improve or get worse. this feasibility study aims to investigate if the diet can be used and is effective in clinical practice. the objectives are to see if this diet is easy to follow, can reduce symptoms of bowel obstruction, can improve quality of life, and reduce admissions to hospital because of bowel blockages. patients at risk of bowel obstruction from colorectal or ovarian cancer are eligible to participate. they will remain in the study for a period of 4 weeks, during which time they will be asked to complete a diet diary and 3 questionnaires.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * able to tolerate oral diet * confirmed diagnosis of sbo due to underlying malignancy to include: 1. patients with colorectal or gynaecological cancers with primary or secondary tumour in situ, undergoing cancer treatment or supportive care. 2. patients diagnosed with advanced inoperable cancers of colorectal or gynaecological origin * presenting in outpatient clinics or admitted from a\&e with a minimum of 2 symptoms of sbo including: abdominal pain, bloating after eating, early satiety, nausea, vomiting * capacity to give informed consent exclusion criteria: * patients under 18 years of age * no symptoms of bowel obstruction * have not already been given advice to follow the 4 stage bowel obstruction diet * unable to tolerate oral diet i.e. enterally or parenterally fed * unable to provide capacity to give informed consent * unable to read and communicate in the english language

Keywords: diet dietary intervention
complete decongestive therapy versus compression bandaging in advanced secondary lymphedema

Conditions: Edema Due to Obstruction of Lymph Vessels or Excision of Lymph Nodes

Summary: the purpose of this study is to: find out the efficacy of using complete decongestive physiotherapy on limb volume in advanced secondary upper and lower extremity lymphedema patients. find out the efficacy of compression bandaging on limb volume in advanced lymphedema patients. this study was conducted to compare between the efficacy of complete decongestive therapy (cdt) and compression bandaging in advanced secondary lower extremity lymphedema.

the study was conducted at the department of plastic surgery, kasr al-ainy hospital. sixty patients of both genders aged from 40 to 55 years old were participated in this study, and they were randomly assigned to two study groups. group i: thirty patients received cdt (60 min of manual lymph drainage mld, compression bandaging, exercises, and skin care). group ii: thirty patients received compression bandaging alone. the same bandaging scheme used for both groups. the therapy included 12 interventions performed 5 days a week, during the first two weeks in addition to another successive two sessions at the third week, i.e., for a total of twelve sessions. evaluation of limb volume using water volumetry and 4-cm truncated cone circumferential measurements were done before treatment application, after 6 sessions (post 1) and after 12 sessions (post 2).

Eligibility criteria:
inclusion criteria: patients with lower limb lymphedema (stage ii and iii) secondary lymphedema aged from 40 to 55 years old, with bmi less than 35 and duration of illness ranged from 3-9 years were included in the study exclusion criteria: the patients were excluded if they have acute erysipelas, acute thrombophlebitis phlebothrombosis and decompensated heart failure.
guided narrative technique after coronavirus outbreak influencing positive and negative emotions and cognition for children--a randomized controlled trial

Conditions: Anxiety and Depression

Summary: at the beginning of 2020, the covid-19 broke out in wuhan, raging across the country quickly afterwards. as a sudden public health emergency, this epidemic caused some stress reactions (including emotional, cognitive, and behavioral reactions) in children. these stress responses, in moderation, may be beneficial as a response to the challenge. however, excessive, and inappropriate stress responses may damage children's mental health, immune function, and daily function. school-based cbt intervention is effective in alleviating children and adolescent anxiety. however, the effect last only shortly. therefore, adding a new intervention component is necessary. guided narrative technique (gnt) is an intervention focusing on narrative coherence and emotional expression. it has writing and drawing versions. the writing version was developed from expressive writing and has a significant effect on the improvement of various negative emotions and negative cognitions of traumatized individuals. in this study, a randomized controlled experiment will be implemented. all participants will take a cbt course first. then, they will be asked to write or draw about the epidemic or other life events using gnt. the study will explore the impact of cbt course combined with gnt on negative emotions and cognition of children after such a public crisis.


Eligibility criteria:
inclusion criteria: * have the ability to read and write in chinese exclusion criteria: * no parental consent
mediators in nasal hyperreactivity in allergic rhinitis and chronic rhinosinusitis

Conditions: Hyperactivity; Allergic Rhinitis Due to House Dust Mite; Chronic Rhinosinusitis With Nasal Polyps

Summary: rhinitis, or inflammation of the nasal mucosa, can present with nasal obstruction, nasal discharge, itch or sneezing. if the sinusal mucosa is involved as well, it is called rhinosinusitis and facial pain or loss of smell is possible. several causes are known, such as an underlying allergy ("allergic rhinitis", ar). if at least 2 symptoms are present for at least 12 weeks, it is called "chronic rhinosinusitis" (crs). up to 2/3 of the ar and crs patients have symptoms upon exposure to triggers such as sudden temperature changes, smoke, fragrances... a phenomenon called "nasal hyperreactivity" (nhr). it is currently not clear why some patients suffer nhr while others do not. in this study, the investigators want to identify the mediators associated with nhr in patients with allergic rhinitis, chronic rhinosinusitis and healthy control subjects.to do so, participants will be provoked with cold, dry air in order to objectively diagnose nhr. before and after provocation, the peak nasal inspiratory flow will be measured and samples will be collected (nasal secretions, biopsies).

patients with perennial allergic rhinitis, chronic rhinosinusitis with nasal polyps and healthy control subjects will be recruited. at baseline, nasal secretions and mucosal biopsies will be collected. after 3 weeks, participants will be provoked with cold, dry air, and samples will be harvested again. a decrease in the peak nasal inspiratory flow of \>20% will be used as a cutoff to define nasal hyperreactivity. nasal secretions will be analysed for various mediators using a multiplex assay. the biopsies will be used for rt-q-pcr and immunohistochemistry of various transient receptor potential (trp) channels.

Eligibility criteria:
inclusion criteria: * 18-65 years * positive skin prick test for house dust mite (for allergic rhinitis group), presence of nasal polyps (for chronic rhinosinusitis with nasal polyps group) * vas-score \>5 for rhino(sinus)itis symptoms exclusion criteria: * positive skin prick test (for chronic rhinosinusitis with nasal polyps group and healthy control group), presence of nasal polyps (for allergic rhinitis group and healthy control group) * acute rhinitis in the past 2 weeks * (history of) immunotherapy for house dust mite * relevant anatomic abnormalities * participation in another clinical trial at the moment of this study. * use of anticoagulants (apart from acetylsalicylic acid) * use of tricyclic antidepressants * history of intranasal drug usage in the past 12 months * pregnancy or breastfeeding * malignancy or severe comorbidity
screening adolescents for type 2 diabetes mellitus in a community clinic

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the prevalence of type 2 diabetes or impaired glucose tolerance in a subset of children 10-19 years of age in an inner city community clinic. the demographics of the clinic are 75% african american, 20% hispanic, 5% other. african american and hispanic patients have a higher prevalence of diabetes with significant morbidity, predominantly from microvascular and macrovascular disease. obesity is commonly seen in patients with type 2 diabetes and contributes to the underlying insulin resistance seen in the disease. obesity is an increasing health problem among adolescents. since type 2 diabetes can be present for several years before diagnosis, it is worrisome that younger children will have undiagnosed type 2 diabetes for years. this will increase the risk of earlier complications in these patients as young adults. we hypothesize that the occurrence of abnormal glucose metabolism in 400 children with either a history of obesity, family history of diabetes mellitus, or symptoms suggestive of diabetes mellitus will be higher than the general pediatric population. we believe that a family based educational program can reduce fasting plasma glucose.

this is a two part study. the first part is a diabetes screening study of 400 adolescent children who have a risk factor for type 2 diabetes to determine the prevalence of abnormal glucose metabolism in such patients. at the time of glucose screening all children will be given a dietary habit survey and two measures of depression/self-esteem to complete so that we may measure the correlation of depression and obesity and depression and abnormal glucose metabolism. the second part tests the efficacy of a family based educational program in lowering fasting glucose in children who screen positive for type 2 dm, hyperinsulinemia, or impaired glucose tolerance. this educational assessment will be administered in an observational non-randomized, non-blinded fashion. the dietary habit survey and the measures of self-esteem and depression will aid us in creating this family based educational study.

Eligibility criteria:
inclusion criteria for screening will be patients who have one of the following: 1. 120% of ideal body weight or bmi\> 27 2. weight greater than 75th percentile 3. family history of type 2 diabetes in first or second degree relative 4. acanthosis nigricans or skin tags as signs of insulin resistance 5. symptoms of hyperglycemia (polyuria, polydipsia, polyphagia, or recurrent infections). 6. symptoms or signs of pcos (hyperandrogenism, hirsutism, irregular menses)
pharmacokinetics, safety and tolerability of single doses of biib033 (opicinumab) produced by 2 manufacturing processes

Conditions: Multiple Sclerosis; Acute Optic Neuritis

Summary: the primary objective of the study is to characterize the pharmacokinetics (pk) of biib033-b and to compare the pk profile with that of biib033-a in healthy volunteers. secondary objectives are: to assess the safety and tolerability of biib033-a and biib033-b; to assess the secondary pk parameters of biib033-a and biib033-b; to assess the immunogenicity of biib033-a and biib033-b.


Eligibility criteria:
key inclusion criteria: * - ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. * - must have a body mass index of 18 to 32 kg/m2, inclusive. * - all male participants and all female participants of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for 6 months after being dosed with study treatment. male participants must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study. male participants must also be willing to refrain from sperm donation for at least 6 months after dosing with study treatment. * - must be in good health as determined by the investigator (or designee), based on medical history and screening evaluations. key exclusion criteria: * - history of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal or other major disease, as determined by the investigator. * - history of or ongoing malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell carcinomas and squamous cell carcinomas that have been completely excised and considered cured at least 12 months prior to day -1). * - serious infection (e.g., pneumonia, septicemia) as determined by the investigator, within the 3 months prior to day -1. * - fever or bacterial or viral infection (including upper respiratory tract infection) within 2 weeks prior to day -1. * - history of severe allergic or anaphylactic reactions, or history of any allergic reaction that in the opinion of the investigator is likely to be exacerbated by any component of the study treatment. * - prior exposure to biib033. * - female participants who are breastfeeding or pregnant at screening or day -1, or plan to become pregnant during the study or during the 6 months following study drug administration. * - history of, or positive test result at screening for, human immunodeficiency virus. * - history of, or positive test result at screening for, hepatitis c virus antibody or hepatitis b virus (defined as positive for hepatitis b surface antigen or hepatitis b core antibody). note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: healthy volunteer opicinumab
evaluation of tolerability and safety of "allergovac poliplus" in polysensitized patients with rhinitis or allergic rhinoconjunctivitis with or without asthma: a study in daily clinical practice

Conditions: Allergic Rhinitis; Rhinoconjunctivitis; Asthma

Summary: this is an observational prospective study to assess the tolerability and safety of treatment of scit allergovac poliplus polymerized in depot presentation. the study drug will be administered either by a 1 day schedule or by a rapid schedule (3 increasing weekly doses at initiation period till maintenance dose is reached) the study population is both: adult and child, polysensitized to at least 2 allergen sources with rhinitis or allergic rhinoconjunctivitis. patients may also present a concomitant mild or moderate asthma. the assignment of a patient to a particular therapeutic strategy will not be decided in advanced by a trial protocol but will be determined by routine clinical practice. the decision of the investigator to prescribe a particular treatment will be clearly dissociated from the decision to include the patient in the study. the patients will not suffer any intervention, whether diagnostic or monitoring, other than the usual in clinical practice.


Eligibility criteria:
inclusion criteria: 1. patients aged between 5 and 60 years who present rhinitis or allergic rhinoconjunctivitis caused by ige-mediated sensitization to more than one allergen source with or without mild / moderate asthma. 2. patients eligible for immunotherapy treatment with allergovac poliplus according to investigator criteria. 3. patients must provide written informed consent. it is the case of children , the legal representative or tutor of the child must sign the inform consent form. exclusion criteria: 1. patients that according to the investigator criteria may present difficulties for understanding the patient information sheet, completing the questionnaires and self-administered scales. 2. patients that according to the investigator may present difficulties to complete the patient diary. 3. patients who are participating in another clinical trial or observational study.

Keywords: mild or moderate
the incidence and factors of brown adipose tissue in chinese

Conditions: Obesity

Summary: previous studies have shown active brown adipose tissue (bat) is present in adults and may play important roles in regulating energy homeostasis. however, the majorities of these studies were done in patients undergoing scanning for cancer surveillance, and may not reflect bat behavior in healthy individuals. in addition, little is known about the ethnic variation in bat activity, particularly in chinese adults. due to the large amount in our cohort, we are able to look at the difference between subjects for cancer surveillance (cs) and subjects for medical check-up (mc), and to clarify the impact of clinical and lifestyle parameters.

we will study scanning database including data from july 2006 to june 2010 in shanghai. bat activity will be measured via 18f-fluorodeoxyglucose (fdg) positron emission tomography/computed tomography (pet/ct). age, imaging date, sex, and outdoor temperature will be collected for all patients. to evaluate the effects of multiple metabolic parameters on bat activity, we will collect height, body weight, fasting plasma glucose (fpg), medical history, diagnosis, smoking, alcohol consumption, exercise, liver triglyceride content, and thyroid metabolic activity for all patients with detectable bat and their negative controls, consisting of two patients who underwent pet/ct scans at the same day but without detectable bat.

Eligibility criteria:
inclusion criteria: * subjects with detectable brown adipose tissue * negative controls, consisting of two subjects who underwent pet/ct scans at the same day but without detectable bat exclusion criteria: * younger than 18 years

Keywords: brown adipose tissue incidence factor human
oral acetyl-l-carnitine therapy reduces fatigue in hepatic encephalopathy

Conditions: Hepatic Encephalopathy

Summary: the aim of this study was to evaluate the effect of exogenous alc on the both physical and mental fatigue in mild and moderate encephalopatic patients.


Eligibility criteria:
inclusion criteria: * 1) chronic hepatitis with spontaneous manifest he (mental state grade 1 or 2 according to the west haven criteria) and an nct-a performance time \>30 seconds; * 2) hyperammonemia (venous ammonia concentration \>50 mmol/l); * 3) cooperative, hospitalised, adult patients with liver cirrhosis diagnosed by clinical, histological and ultrasonographic findings (reduced dimensions of the liver as well as splenomegaly) and oesophageal varices at stage ii and iii observed by endoscopy. exclusion criteria: * 1) major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis; * 2) acute superimposed liver injury; * 3) patient with other neurological disease and metabolic disorders, diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease; * 4) alcoholic -toxic cirrhosis because toxic brain damage may interfere with the assessment of he; * 5) severe he; * 6) administration of anti-he medications such as neomycin, branched-chain amino acids; * 7) any additional precipitating factors such as high protein intake (additional high-protein meals), constipation or intake of psycho stimulants, sedatives, antidepressants, benzodiazepines, or benzodiazepines-antagonists (flumazenil), beta-adrenergic blockers, neuromuscular blocking agents, certain antibiotics; * 8) patients with fever, sepsis or shock were also excluded to avoid variations caused by body temperature; * 9) illiteracy.